Recall Z-0818-2008 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cordis Corporation
CORDIS "Fire Star" 2.00 x 30, Single Marker Band, Dilatation Catheter, Catalog # 8013020S, Distributed by Cordis Corporation, Miami Lakes, FL 33014
| Date | Feb 6, 2008 (initiated Jan 14, 2008) |
| Status | Terminated |
| Reason | Slow Deflation or No Deflation |
| Root cause | Process control |
| Action | Cordis initated the recall on 1/14/2008. For U.S. customers: An Urgent Medical Device Recall letter and an Acknowledgement Form was sent to the following 4 individuals in each account: Cath Lab Director, Operating Room Director, Materials Director, Risk Manager; to be followed up with direct Cordis representative contact to facilitate obtaining signature, faxing form, collecting and returning units. For non-US customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries. All users were |
| Quantity | 133,300 units total for recalls Z-0747-0824-2008 |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.